Zoe Hoare

Goal-Oriented Cognitive Rehabilitation for People With Early-Stage Alzheimer Disease: A Single-Blind Randomized Controlled Trial of Clinical Efficacy

OBJECTIVES To provide evidence regarding the clinical efficacy of cognitive rehabilitation (CR) in early-stage Alzheimer disease (AD). DESIGN Single-blind randomized controlled trial comparing CR with relaxation therapy and no treatment. SETTING Outpatient, community-based setting. PARTICIPANTS Sixty-nine individuals (41 women, 28 men; mean age 77.78 years, standard deviation 6.32, range = 56-89) with a diagnosis of AD or mixed AD and vascular dementia and a Mini-Mental State Examination score of 18 or above, and receiving a stable dose of acetylcholinesterase-inhibiting medication. Forty-four family carers also contributed. INTERVENTION Eight weekly individual sessions of CR consisting of personalized interventions to address individually relevant goals supported by components addressing practical aids and strategies, techniques for learning new information, practice in maintaining attention and concentration, and techniques for stress management. MEASUREMENTS The primary outcomes were goal performance and satisfaction, assessed using the Canadian Occupational Performance Measure. Questionnaires assessing mood, quality of life and career strain, and a brief neuropsychological test battery were also administered. A subset of participants underwent functional magnetic resonance imaging (fMRI). RESULTS CR produced significant improvement in ratings of goal performance and satisfaction, whereas scores in the other two groups did not change. Behavioral changes in the CR group were supported by fMRI data for a subset of participants. CONCLUSIONS The findings support the clinical efficacy of CR in early-stage AD. CR offers a means of assisting people with early-stage AD and their families in managing the effects of the condition.

REMCARE: reminiscence groups for people with dementia and their family caregivers – effectiveness and cost-effectiveness pragmatic multicentre randomised trial

OBJECTIVES The aim of the REMiniscence groups for people with dementia and their family CAREgivers (REMCARE) study was to assess the effectiveness and cost-effectiveness of joint reminiscence groups for people with dementia and their family caregivers as compared with usual care. DESIGN A multicentre, pragmatic randomised controlled trial with two parallel arms - an intervention group and a usual-care control group - was carried out. A restricted dynamic method of randomisation was used with an overall allocation ratio of 1 : 1, restricted to ensure intervention groups of a viable size. Assessments, blind to treatment allocation, were carried out at baseline, 3 months and 10 months (primary end point). SETTING Most participants were recruited through NHS Memory Clinics and Community Mental Health Teams for older people. Assessments were usually carried out in the persons home, and treatment groups were held in a variety of community settings. PARTICIPANTS A total of 488 individuals (mean age 77.5 years) with mild to moderate dementia (meeting Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria), who were initially living in the community, and who had a relative or other caregiver maintaining regular contact, who could act as an informant and was willing and able to participate in the intervention, were recruited to the study. Most carers were spouses (71%). A total of 350 dyads completed the study. INTERVENTIONS The intervention consisted of joint reminiscence groups held weekly for 12 consecutive weeks, followed by monthly maintenance sessions for a further 7 months. The sessions followed a treatment manual, and were led by two trained facilitators in each centre, supported by a number of volunteers. Up to 12 dyads were invited to attend each group. MAIN OUTCOME MEASURES The primary outcome measures were self-reported quality of life for the person with dementia and psychological distress for the carer [General Health Questionnaire-28 item version (GHQ-28)]. Secondary outcome measures included autobiographical memory and activities of daily living for the person with dementia, carer stress for the carer and mood, relationship quality and service use and costs for both parties. RESULTS The intention-to-treat analysis identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes [self-reported quality of life in Alzheimers disease: mean difference 0.07, standard error (SE) 0.65; F = 0.48; p = 0.53]. Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a subscale of the GHQ-28 at the 10-month end point (mean difference 1.25, SE 0.5; F = 8.28; p = 0.04). Compliance analyses suggested some benefits for people with dementia who attended more reminiscence sessions; however, carers attending more groups showed increased caregiving stress. Use of health- and social-care services was modest, with no significant difference in service use between conditions. Owing to negligible difference in quality-adjusted life-year gains (derived from European Quality of Life-5 Dimensions) between the conditions the planned full economic analysis was curtailed. CONCLUSIONS This trial does not provide support for the effectiveness or cost-effectiveness of joint reminiscence groups for people with dementia and their carers. Although there may be some beneficial effects for people with dementia who attend sessions as planned, this must be viewed in the context of raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions. TRIAL REGISTRATION Current Controlled Trials ISRCTN42430123. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 48. See the HTA programme website for further project information.

Generalized method for adaptive randomization in clinical trials

A flexible, generalized method of treatment allocation is proposed. The method uses a set of controlling parameters that enables the generic algorithm to produce a family of possible outcomes ranging from simple randomization to deterministic allocation. The method controls balance at stratum level, stratification level and overall without detriment to the predictability of the method. The paper lists the desirable characteristics of allocation methods and shows that the proposed method fulfils the majority and is easy to use in the clinical context, once the coding has been established. An explanation of the method for 2, 3 and 4 treatment group allocations is given. Simulations demonstrate the flexibility of the method.

Maintenance cognitive stimulation therapy for dementia: single-blind, multicentre, pragmatic randomised controlled trial

BACKGROUND There is good evidence for the benefits of short-term cognitive stimulation therapy for dementia but little is known about possible long-term effects. AIMS To evaluate the effectiveness of maintenance cognitive stimulation therapy (CST) for people with dementia in a single-blind, pragmatic randomised controlled trial including a substudy with participants taking acetylcholinesterase inhibitors (AChEIs). METHOD The participants were 236 people with dementia from 9 care homes and 9 community services. Prior to randomisation all participants received the 7-week, 14-session CST programme. The intervention group received the weekly maintenance CST group programme for 24 weeks. The control group received usual care. Primary outcomes were cognition and quality of life (clinical trial registration: ISRCTN26286067). RESULTS For the intervention group at the 6-month primary end-point there were significant benefits for self-rated quality of life (Quality of Life in Alzheimers Disease (QoL-AD) P = 0.03). At 3 months there were improvements for proxy-rated quality of life (QoL-AD P = 0.01, Dementia Quality of Life scale (DEMQOL) P = 0.03) and activities of daily living (P = 0.04). The intervention subgroup taking AChEIs showed cognitive benefits (on the Mini-Mental State Examination) at 3 (P = 0.03) and 6 months (P = 0.03). CONCLUSIONS Continuing CST improves quality of life; and improves cognition for those taking AChEIs.

Cognitive stimulation therapy (CST) for people with dementia—who benefits most?†

The efficacy of cognitive stimulation therapy (CST) has been demonstrated, but little is known about the characteristics of people with dementia, which may predict a more positive response to CST. This study sought to investigate which factors may predict response to CST.

REMCARE: pragmatic multi-centre randomised trial of reminiscence groups for people with dementia and their family carers: effectiveness and economic analysis

Background Joint reminiscence groups, involving people with dementia and family carers together, are popular, but the evidence-base is limited. This study aimed to assess the effectiveness and cost-effectiveness of joint reminiscence groups as compared to usual care. Methods This multi-centre, pragmatic randomised controlled trial had two parallel arms: intervention group and usual-care control group. A restricted dynamic method of randomisation was used, with an overall allocation ratio of 1:1, restricted to ensure viable sized intervention groups. Assessments, blind to treatment allocation, were carried out at baseline, three months and ten months (primary end-point), usually in the persons home. Participants were recruited in eight centres, mainly through NHS Memory Clinics and NHS community mental health teams. Included participants were community resident people with mild to moderate dementia (DSM-IV), who had a relative or other care-giver in regular contact, to act as informant and willing and able to participate in intervention. 71% carers were spouses. 488 people with dementia (mean age 77.5)were randomised: 268 intervention, 220 control; 350 dyads completed the study (206 intervention, 144 control). The intervention evaluated was joint reminiscence groups (with up to 12 dyads) weekly for twelve weeks; monthly maintenance sessions for further seven months. Sessions followed a published treatment manual and were held in a variety of community settings. Two trained facilitators in each centre were supported by volunteers. Primary outcome measures were self-reported quality of life for the person with dementia (QoL-AD), psychological distress for the carer (General Health Questionnaire, GHQ-28). Secondary outcome measures included: autobiographical memory and activities of daily living for the person with dementia; carer stress for the carer; mood, relationship quality and service use and costs for both. Results The intention to treat analysis (ANCOVA) identified no differences in outcome between the intervention and control conditions on primary or secondary outcomes (self-reported QoL-AD mean difference 0.07 (-1.21 to 1.35), F = 0.48, p = 0.53). Carers of people with dementia allocated to the reminiscence intervention reported a significant increase in anxiety on a General Health Questionnaire-28 sub-scale at the ten month end-point (mean difference 1.25 (0.25 to 2.26), F = 8.28, p = 0.04). Compliance analyses suggested improved autobiographical memory, quality of life and relationship quality for people with dementia attending more reminiscence sessions, however carers attending more groups showed increased care-giving stress. Economic analyses from a public sector perspective indicated that joint reminiscence groups are unlikely to be cost-effective. There were no significant adverse effects attributed to the intervention. Potential limitations of the study include less than optimal attendance at the group sessions—only 57% of participants attended at least half of the intervention sessions over the 10 month period, and a higher rate of study withdrawal in the control group. Conclusions This trial does not support the clinical effectiveness or cost-effectiveness of joint reminiscence groups. Possible beneficial effects for people with dementia who attend sessions as planned are offset by raised anxiety and stress in their carers. The reasons for these discrepant outcomes need to be explored further, and may necessitate reappraisal of the movement towards joint interventions. Trial Registration ISRCTN Registry ISRCTN42430123

Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial

BackgroundImproving the quality of care for people with dementia and their carers has become a national priority in many countries. Cognitive Stimulation Therapy (CST) groups can be beneficial in improving cognition and quality of life for people with dementia. The aim of the current study is to develop and evaluate a home-based individual Cognitive Stimulation Therapy (iCST) programme for people with dementia which can be delivered by their family carer.MethodsThis multi-centre, pragmatic randomised controlled trial (RCT) will compare the effectiveness and cost-effectiveness of iCST for people with dementia with a treatment as usual control group. The intervention consists of iCST sessions delivered by a carer for 30 minutes, 3 times a week over 25 weeks.For people with dementia the primary outcome measures are cognition assessed by the ADAS-Cog, and quality of life assessed by QoL-AD. For carers, quality of life using the SF-12 is the primary outcome measure. Using a 5% significance level, comparison of 306 participants will yield 80% power to detect an effect size of 0.35 for cognition as measured by the ADAS-Cog, and quality of life as measured by the QoL-AD. Quality of life for the carer will be measured using the SF-12. The trial will include a cost-effectiveness analysis from a public sector perspective.DiscussionThe UK Department of Health has recently stressed that improving access to psychological therapies is a national priority, but many people with dementia are unable to access psychological interventions. The development of a home-based individual version of CST will provide an easy to use, widely available therapy package that will be evaluated for effectiveness and cost-effectiveness in a multi centre RCT.

Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial

BackgroundPeer support interventions can improve carer wellbeing and interventions that engage both the carer and person with dementia can have significant mutual benefits. Existing research has been criticised for inadequate rigour of design or reporting. This paper describes the protocol for a complex trial that evaluates one-to-one peer support and a group reminiscence programme, both separately and together, in a factorial design.DesignA 2 × 2 factorial multi-site randomised controlled trial of individual peer support and group reminiscence interventions for family carers and people with dementia in community settings in England, addressing both effectiveness and cost-effectiveness.DiscussionThe methods described in this protocol have implications for research into psychosocial interventions, particularly complex interventions seeking to test both individual and group approaches.Trial RegistrationISRCTN37956201

Landscapes of Naïve Bayes classifiers

The performance of the Naïve Bayes classifier (NB) is of interest to many researchers. The desire to improve upon the apparent good performance of NB while maintaining its efficiency and simplicity is demonstrated by the variety of adaptations to NB in the literature. This study takes a look at 37 such adaptations. The idea is to give a qualitative overview of the adaptations rather than a quantitative analysis of their performance. Landscapes are produced using Sammon mapping, Principal Component Analysis (PCA) and Self-Organising feature Maps (SOM). Based on these, the methods are split into five main groups—tree structures, feature selection, space transformation, Bayesian networks and joint features. The landscapes can also be used for placing any new variant of NB to obtain its nearest neighbours as an aid for comparison studies.

AwareCare: Development and validation of an observational measure of awareness in people with severe dementia

Signs of sensory and perceptual awareness can be observed in people with very severe dementia, and may be influenced by the extent to which the environment offers appropriate stimulation. We developed an observational tool, AwareCare, which care staff can use to identify signs of awareness in residents with very severe dementia, based on the concept of the Wessex Head Injury Matrix (WHIM). Using WHIM items as a guide, and following focus groups with care staff and family members, an expert panel identified 28 environmental stimuli and 35 response categories for the initial version of AwareCare. After baseline assessments of cognition, well-being and quality of life were taken, 40 residents were observed individually for 30 minutes on 5 occasions. Based on the observational data, 10 stimulus categories and 14 response categories were identified for further analysis and formed the final version of AwareCare. All participants showed awareness to varying degrees. Social stimuli elicited the most responses. Greater awareness was associated with better cognitive function, self-care, mobility, and responsiveness, but not with proxy-rated quality of life. Understanding the nature of awareness in this group is an important element in ensuring appropriate levels of interaction and stimulation, and hence enhancing quality of care.